+Step 1: How to Prepare

Complete online training courses. All principal investigators, co-investigators, advisors and research assistants must complete two courses, one in human research and one in responsible conduct of research, at the CITI website. Registration instructions are shown at the bottom of our Mandatory Training page.

Register on IRBNet at www.irbnet.org. All principal investigators, co-investigators and advisors must register. Registration is optional for research assistants. Click on the New User Registration link at the top right of IRBNet's home page and enter requested information. When asked for institutional affiliation, search for and select Marywood University. After clicking the register button, you will be sent a confirmation email message. Click the confirmation link in the email message to finalize registration.

Decide the review type based on activities, population and risk. See decision charts, policies, or consult with your advisor or our office.

Download and create supporting documents. IRB forms and templates are available on the IRB's instructions page (right menu). Exempt forms are found at the ERC's website (left menu - Forms button).

Proofread and run a spellcheck in your word processing software. Check for errors prior to submission. Editorial services should not be sought from the board and often slow down review.

Review the meeting schedule and submission deadlines. Follow deadlines, allowing adequate review time. Student investigators must apply during the semester prior to the one in which they plan to graduate, unless taking a two semester research course (e.g., SSW 701/702, PSYCH 421/422) with a built-in deadline of February 1st.

+Step 2: How to Submit at IRBNet

Sign your package. Signatures are required of the Principal Investigator (PI), the advisor, or any co-investigators.

Submit your package. The upload itself does not send it to a board. Click the submit button in IRBNet's left menu for it to be officially transmitted.

+Step 3: How to Respond

Monitor your e-mail account. The board will send notification when a decision letter has been uploaded to IRBNet (Project Overview button on left>Review Details link in middle of page>Board Documents table at the bottom).

Create a package of requested modifications.

Do not create a new project or ask for the initial package to be unlocked! The original package must remain locked to maintain a submission trail. Create a follow-up package within your existing project (i.e., IRBNet# 12345-1, 12345-2, 12345-3, etc.). Review our written IRBNet Instructions for steps to follow.

Track your changes. See How to Track Changes for assistance with enabling tracking to show modifications.

Upload your documents.

Sign your package: The Principal Investigator must sign every package.

Submit your package. The upload itself does not send it to a board. Click the submit button in IRBNet's left menu for it to be officially transmitted.

Monitor your e-mail account. An approval notice will be sent via email, prompting you to log in at IRBNet to retrieve your approval letter and stamped materials. Stamped versions of materials must be used unless otherwise noted in your letter. The expiration date and reporting requirements will be contained in the letter.

+Step 4: What to Report After Approval

Six-month Status Report (IRB reviewed studies only): This is due six months after approval. On IRB forms page, find form at right.

Closure Report (All studies): A closure report is due prior to the 1-year expiration date. Find the form to the right (for IRB) or the ERC's website (forms button). If activities will continue beyond the 1-year approval period, you must apply for renewal (continuing review), allowing ample time for review so there is no lapse. All research activities must cease as of the expiration date, unless the board approves a renewal. Projects may not be closed until both data collection and analysis have been completed. If analysis is ongoing, renewal is required. See our Continuing Review (Renewal) form on the right side of this page (IRB) or the ERC's website.

Deviations, Violations, Unanticipated Problems or Serious Adverse Events (All studies): Any of these must be reported in a timely fashion. Please see our Mandatory Reporting policies and procedures, as well as the Deviation/Violation and Adverse Event/Unanticipated Problem forms on the right side of this page (for IRB). ERC forms may be found on the ERC's website.

Revisions to Approved Research (All studies): Researcher initiated changes after approval, however minor, must be reviewed and approved prior to implementation. See our Revisions to IRB Approved Research Request form on the right side of this page (for IRB) or the ERC's website.